Alere San Diego, Inc. Recall: The Cholestech LDX¿ System combines enzymatic methodology an
Alere San Diego, Inc. Recall: The Cholestech LDX¿ System combines enzymatic methodology an is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Alere San Diego, Inc.; Product: The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, H
| Recalling firm | Alere San Diego, Inc. |
|---|---|
| Product | The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987 |
| Reason for recall | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA, NY, MO, CO, AZ, OH, HI, VA, KS, IN, AL. OUS: GB, ZA, NO, NL, FI, IE, IQ, IT, CH, DE, ES, HU, SI, NA, PT, IS, NG, PL, CY, TN, BH, ID, MY, AU, SG, JP, IN, BD, KR, HK, BR, CO, AR, CA |
| Recall initiated | 20220624 |
| Recall number | Z-1508-2022 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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